Pharmacokinetic and Pharmacodynamic Profile of Insulin Lispro Using Needle-Free Jet Injection Technology
Phase 4
Completed
- Conditions
- Healthy
- Registration Number
- NCT02443714
- Lead Sponsor
- Chongqing Medical University
- Brief Summary
Needle-free jet injector provides an alternative for patients with diabetes treated by insulin. This study aimed at evaluating pharmacokinetics and pharmacodynamics (PK-PD) profiles of lispro administered by jet injector and conventional pen.
- Detailed Description
This is a randomized, double-blind, double-dummy, crossover study. Eighteen healthy volunteers will be recruited. Lispro (0.2 units/kg) will be administered by jet injector or by conventional pen and a seven-hour euglycemic clamp test will be performed. PK-PD profiles of lispro will be calculated.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
- The range of height should be 170±10cm.
- The range of weight should be ±10%kg.
- Liver and renal function should be normal.
- Health subjects with no chronic diseases or medications.
Exclusion Criteria
- Drug allergy, history of allergic disorders or allergies.
- A history of liver or kidney disease.
- Smoker, drinkers.
- Subjects who participated in other drug trials within a month.
- Subjects who used medication which is known to organ damage.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Early insulin exposure The area under the curve (AUC) of insulin from 0 to 30min (AUCins, 0-30min)
- Secondary Outcome Measures
Name Time Method Pharmacokinetics 50% insulin absorption time (Ins-TAUC50%) Pharmacodynamics Maximum GIR (GIRmax)
Trial Locations
- Locations (1)
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
The First Affiliated Hospital of Chongqing Medical University🇨🇳Chongqing, Chongqing, China